Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis.

摘要: A prospective, multicenter, randomized, controlled 12-week study was undertaken to evaluate the effectiveness of a human fibroblast-derived dermis for treating foot ulcers in diabetic patient. This report summarizes findings from one center. Following 2-week screening period, patients were randomized either (HFDD) (Dermagraft ® ) plus saline-moistened gauze or control group (CT) alone. Effectiveness end points were: 1) wound closure by week 12, 2) time closure, and 3) percent 12. Safety assessed review adverse events laboratory findings. Patients HFDD received an application at day 0 up seven additional treatments. All each shoes with custom-molded inserts seen weekly. The population comprised 28 (14 HFDD/14 CT) chronic (>6 weeks' duration screening). By significantly more healed than CT (71.4% versus 14.3%, p=.003). Healed achieved faster (p = .004). treated showed statistically significant higher 12 did .002). who experienced infection involving their less group. It concluded that is safe effective treatment patients.